Study of 3D Scanning for Adolescent Scoliosis
Study Details
Study Description
Brief Summary
The investigators aim to validate three-dimensional topographical scanning technology as a tool for evaluation of scoliosis. Through the incorporation of 3D topographical technology in the measurement of deformity, the investigators hope to validate a novel approach to quantify deformity progression and provide an accessible alternative to traditional radiographic workup.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The study design will be prospective observational. Patients 10 to 18 years old being evaluated or followed for scoliosis will be included. Those unable to complete the consent and assent processes will not be enrolled. Members of the research team will review the clinic schedule through EPIC each week to identify eligible patients. Member of the patient's care team, such as the physician, will introduce the study to the patient. If the patient and the patient's caregivers are interested in learning more and/or participating, a member of the research team will provide study-related information and obtain informed consent via written or electronic consent, assent, and, if necessary, short form consent.
If a patient consents to participate, members of the research team will conduct the 3D topographical scan in a private room in the clinic. This involves 360 degree scans using a smartphone camera. Participants will also receive any standard of care x-rays during the visit. The investigators will then analyze the ability of the 3D smartphone scan to estimate the Cobb Angle measured on the X-ray, to infer the magnitude of the scoliosis deformity.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Intervention This study will have one cohort. This group of patients will undergo 3D scanning with a smartphone, and will also have standard of care diagnostics, such as an X-ray. |
Diagnostic Test: 3D topographical scan
Subjects will undergo a quick, radiation-free, no contact 3D scan using a smartphone.
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Outcome Measures
Primary Outcome Measures
- Accuracy of scanning device to predict clinically significant Cobb Angle [Through study completion, an average of 3 months]
The primary study endpoint, or primary outcome, is whether the 3D scan's predicted probability of clinically significant Cobb angle correlates with the ground truth radiograph obtained Cobb angle at the defined rate. The percentage (%) of patient scans with predicted probabilities that correlate with ground truth results will be reported.
Secondary Outcome Measures
- Repeatability of 3D scan analysis [Within 48 hours]
After the 3D scan is obtained, several personnel will align the scan relative to grid coordinates, and place a region of interest on the back of the scan. Measurements will be performed which will generate an asymmetry value, which is used to assess Cobb Angle correlation. The investigators will determine the repeatability of this manual scan assessment process.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Ages 10 and 18 years old
Exclusion Criteria:
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Scoliosis caused by another condition (e.g., secondary scoliosis)
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Parents/guardians unable to consent
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English is not the primary language (to avoid miscommunication)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University School of Medicine | Palo Alto | California | United States | 94063 |
| 2 | Duke University | Durham | North Carolina | United States | 27708 |
Sponsors and Collaborators
- NSite Medical
Investigators
- Principal Investigator: Kali Tileston, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 54101